CAJ | 학술논문

目的：评价新型骨修复材料聚乳酸-乙醇酸复合中药自然铜活性骨修复支架的生物安全性。方法根据医疗器械生物学评价标准的要求，选取了溶血试验、细胞毒性试验、遗传毒性试验、刺激与致敏试验、全身毒性试验、植入试验等，全方位评价该新型材料的生物安全性。结果聚乳酸-乙醇酸复合中药自然铜活性骨修复支架的血液相容性良好，无全身毒性和细胞毒性，未发现短期遗传毒性，无皮肤刺激和致敏作用，材料植入骨后周围组织反应正常，骨修复情况良好。结论聚乳酸-乙醇酸复合中药自然铜活性骨修复支架是一种生物相容性好的骨修复材料，可安全应用于临床。
목적：평개신형골수복재료취유산-을순산복합중약자연동활성골수복지가적생물안전성。방법근거의료기계생물학평개표준적요구，선취료용혈시험、세포독성시험、유전독성시험、자격여치민시험、전신독성시험、식입시험등，전방위평개해신형재료적생물안전성。결과취유산-을순산복합중약자연동활성골수복지가적혈액상용성량호，무전신독성화세포독성，미발현단기유전독성，무피부자격화치민작용，재료식입골후주위조직반응정상，골수복정황량호。결론취유산-을순산복합중약자연동활성골수복지가시일충생물상용성호적골수복재료，가안전응용우림상。
Objective To evaluate biological safety of poly lactic-co-glycolic acid( PLGA )/pyrite composite active bone repalr scaffold. Methods According to biological evaluation criterion of medical devices, we selected hemolytic test, cytotoxicity test, genotoxicity test, tests for irritation and delayed-type hypersensitivity,general toxicity test and implantation test,to evaluate biological safety of the new materials. Results PLGA /pyrite composite active bone repalr scaffold had good blood compatibility,without general toxicity,cell toxicity,skin irritation and sensitization. The tissue reaction was normal after planting to the bone and the bone repalring was in good condition. Conclusions PLGA/ pyrite composite active bone repalr scaffold was one kind of bone repalr material with good biocompatibility and could be safely applied to clinical use.